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NCT05938413 · ClinicalTrials.gov registry record · NA
Community Health Worker And MHealth to ImProve Viral Suppression (CHAMPS Pilot)
A NA study, sponsored by Columbia University.
- Completed
- Registry status
- NA
- Development phase
- 40
- Enrollment target
NCT05938413: Completed NA study, sponsored by Columbia University.
NCT05938413 is a NA study that has completed, run by Columbia University. The registered enrollment target is 40 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (97% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05938413, a NA study, has completed, sponsored by Columbia University.
- COMPLETED
- Registry status
- NA
- Development phase
- 40 participants
- Enrollment target
Study Summary
The overall goal of this study is to evaluate the feasibility of a remotely delivered CHAMPS intervention for people living with HIV (PLWH) in a randomized controlled trial. The proposed trial is scientifically significant in representing a principled and systematic effort to test the efficacy of a combined community health worker (CHW) and smartphone intervention linked to a smart pill box for antiretroviral (ART) adherence in PLWH in the United States (US). Guided by a rigorous theoretical model of supportive accountability and building on preliminary work, this intervention has the potential to enable PLWH to self-manage their ART regimens while CHW monitor their ART adherence in real-time ultimately leading to viral suppression and ART adherence.
Primary Outcome
Using dried blood samples or electronic health records obtained during study visits, viral load levels will be used to assess ART adherence. The number of participants with detectable viral load (\>= 200 copies/mL in EHR; \>= 500 copies/mL in DBS) and not detectable viral load (\<200 copies/mL in EHR, \<500 copies/mL in DBS) will be reported. The intervention effect at the 3 month follow up was adjusted for various values of baseline.
Interventions
- BEHAVIORAL CHW Sessions
- DEVICE Wise App with medication adherence reminders
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 40 participants |
| Start Date | 2023-07-20 |
| Est. Completion | 2024-05-07 |
| Phase | NA |
What the finished NCT05938413 record still lists
NCT05938413 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 40 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (97% lower).
The record links to 0 conditions, and to 2 interventions - of which CHW Sessions is the first listed.
NCT05938413 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT05938413 about?
NCT05938413 is a clinical study titled "Community Health Worker And MHealth to ImProve Viral Suppression (CHAMPS Pilot)". The overall goal of this study is to evaluate the feasibility of a remotely delivered CHAMPS intervention for people living with HIV (PLWH) in a randomized controlled trial. The proposed trial is scientifically significant in representing a principled and systematic effort to test the efficacy of a ...
What is the current status of trial NCT05938413?
This trial is currently completed. It is a NA study. The enrollment target is 40 participants. The study started on 2023-07-20. Estimated completion is 2024-05-07.
What interventions are being tested in trial NCT05938413?
The interventions under investigation include: CHW Sessions (BEHAVIORAL), Wise App with medication adherence reminders (DEVICE).
Who is sponsoring clinical trial NCT05938413?
This trial is sponsored by Columbia University, which has 958 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT05938413's enrollment target sits among peer trials
40 1447th of 2000 higher than 465 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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